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Image filing software NAVIS-EX

FDA UDI

Class I (US FDA UDI)

by Nidek, Inc.

Identity

Trade Name
Image filing software NAVIS-EX FDA UDI
Generic Name
Eye anterior segment analyser software FDA UDI
Device Name
The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client PC. FDA UDI
Model / Reference
1.12 FDA UDI
Description
The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client PC. FDA UDI

Identifiers

Primary DI / UDI-DI
04987669200636 FDA UDI
FDA Product Code
NFG FDA UDI
NFF FDA UDI
MYC FDA UDI
HKI FDA UDI
HPT FDA UDI
OBO FDA UDI
HJO FDA UDI
NFJ FDA UDI
GMDN Term
Eye anterior segment analyser software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.2020 FDA UDI
892.2010 FDA UDI
886.1570 FDA UDI
886.1120 FDA UDI
886.1605 FDA UDI
886.1850 FDA UDI
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Eye anterior segment analyser softwarePosterior eye segment analyser software

Image filing software NAVIS-EX by Nidek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Posterior eye segment analyser software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nidek, Inc.

Sources (1)

  • FDA UDI 39e20634-d95f-46d9-90d7-fc35645c10db 34 fields · synced May 30, 2026